8th CMO Quality Oversight & Risk Management Summit - Boston, MA

8th CMO Quality Oversight & Risk Management Summit
March 21–22, 2018
Boston, MA
Boston, MA

Ensuring Compliance and Robust Partnerships Through Rigorous Discourse and Disseminations of Tactical Operations, Oversight and Quality Systems

Agenda – 8th CMO Quality Oversight & Risk Management Summit

Day One


9:00AM – 9:15AM

Chair’s Opening Remarks

10:15AM – 11:00AM

Ensure Quality Through Effective Relationship Management and CMO Support

Natasha Bussard, Director of Research and Development, UPM PHARMACEUTICALS
Laura Kalegaric, Associate Director, Quality Assurance, AKEBIA THERAPEUTICS

11:00AM – 11:30AM

Networking Break

11:30AM – 12:15PM

Hear Compliance Trends and Updates: Operations, Inspections, Quality Agreements and Case Examples

Paula Katz, Director of Manufacturing Quality Guidance and Policy, Office of Compliance, CDER, FDA

12:15PM – 1:15PM


1:15PM – 2:00PM

Case Study: Limit the Impact of Product Recall Through Strategic Interactions With CMOs

Gerald Zemble, Senior Manager, Supplier Quality, PURDUE PHARMACEUTICALS

2:00PM – 2:45PM

Assure Quality With Collaborative Ventures From Disparate Deal Types

Joseph Kudla, Associate Director QA Operations/Systems, ASTRAZENECA/MEDIMMUNE

2:45PM – 3:15PM

Networking Break

3:15PM – 4:00PM

Case Study: Avoid Surprises by Performing Robust Due Diligence in Partner Selection

Suzanne Murray, VP of Quality, AGIOS PHARMACEUTICALS

4:00PM – 4:45PM

Case Study: Hear Celgene's Approach to Streamlining Procedures

Eva Urban, Senior Manager, OpEx Risk Management, CELGENE

Day Two


8:00AM – 9:00AM

Continental Breakfast

9:10AM – 9:45AM

Interactive Exercise

9:45AM – 10:30AM

Compare and Contrast Technical (Quality) Agreements Guidelines in the U.S. and the EU

Nadine Jahn, Senior Manager, Third Party Quality Management, BOEHRINGER INGELHEIM

10:30AM – 11:15AM

Case Study: Discuss CMO-Owner Collaboration in Continuous Manufacturing that Maintains Quality While Maximizing Savings  

Michelle Bailey, Associate Director, Validation for Continuous Manufacturing and Automation, VERTEX

11:15AM – 11:45AM

Networking Break

11:45AM – 12:30PM

Achieve Organizational Excellence and a Culture of Quality: Medtronic's Approach

Prakash Patwardhan, Director of Corporate Quality, MEDTRONIC

12:30PM – 1:30PM


1:30PM – 2:15PM

Explore the Difference Between Quality Agreements and Contract Manufacturing in the U.S. and Canada

Sandra Edwards, Director, Corporate Quality Compliance and Risk Management, TARO PHARMACEUTICALS

2:15PM – 3:00PM

Case Study: Study Lessons Learned in Tech Transfers in Emerging Markets

Eyad Salman, Principal Quality Site Manager, GENENTECH

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